An investigational agent, lenvatinib, has shown favorable activity when compared with a placebo with high response rates and delayed disease progression….
The SELECT study was highlighted at the 2014 Annual Meeting of the American Society of Clinical Oncology during a press briefing. Investigator Lori J. Wirth, MD, assistant professor of medicine at Harvard Medical School and medical director of the Center for Head and Neck Cancer at Massachusetts General Hospital in Boston and colleagues conducted a phase III, randomized, multicenter, double-blinded, placebo controlled trial of lenvatinib in patients with refractory differentiated thyroid cancer. The study contained 392 randomized patients with documented disease progression within 13 months. Patients were randomized in a 2:1 ratio to lenvatinib, 24 mg/day in a 28-day cycle or a placebo was given. The median age of patients was 63 years old. Patients in the placebo group were allowed to cross over to open-label lenvatinib upon disease progression. Dr. Wirth reported there might be difficulty in interpreting data due to the study’s crossover design. She explained how the study was ongoing, and that patients were still followed. The results showed that two-thirds of patients responded to treatment with lenvatinib. Additionally, a significantly delayed disease progression was seen when lenvatinib was compared with the placebo. The mortality rate was lower in the group that received lenvatinib, 27.2%, than in the placebo group, 35,9%. Eisai funded the study, and several of the authors have financial relationships with the industry, which is noted in the abstract of the study.
Dr. Wirth stated, "There was a very significant progression-free survival, and the response rate was very high — at 65%."
Stephen Liu, MD, assistant professor of medicine at the Georgetown Lombardi Comprehensive Cancer Center, in Washington, DC, commented, "Sorafenib was recently approved in this patient population after demonstrating a progression-free survival of 10.8 months, but the Sorafenib trial and the SELECT trial cannot be directly compared." He reported the response rate of lenvatinib was over 60%, whereas only 12% responded to Sorafenib in its phase III study. Furthermore, it was noted both agents are oral tyrosine kinase inhibitors.
- Sorafenib (Nexavar) was recently approved by the FDA for patients with radioiodine-resistant advanced differentiated thyroid cancer
- An investigational agent lenvatinib has shown favorable activity when compared with a placebo
- The results showed that two-thirds of patients responded to treatment with lenvatinib. Additionally, a significantly delayed disease progression was seen when lenvatinib was compared with the placebo.